Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
  • A61M25/09—Guide wires
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
  • A61M25/09—Guide wires
  • A61M2025/09058—Basic structures of guide wires
  • A61M2025/09075—Basic structures of guide wires having a core without a coil possibly combined with a sheath
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
  • A61M25/09—Guide wires
  • A61M2025/09133—Guide wires having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
  • A61M25/09—Guide wires
  • A61M2025/09175—Guide wires having specific characteristics at the distal tip

Definitions

• the present disclosure pertains to medical devices, and methods for manufacturing medical devices. More particularly, the present disclosure pertains to medical device for accessing body lumens.
• intracorporeal medical devices have been developed for medical use, for example, intravascular use. Some of these devices include guidewires, catheters, and the like. These devices are manufactured by any one of a variety of different manufacturing methods and may be used according to any one of a variety of methods. Of the known medical devices and methods, each has certain advantages and disadvantages. There is an ongoing need to provide alternative medical devices as well as alternative methods for manufacturing and using medical devices.
• An example medical device includes a medical guidewire.
• the guidewire may include a core wire having a longitudinal axis.
• the core wire may include a distal constant diameter, a first tapered section, an intermediate constant diameter section, a second tapered section, and a proximal constant diameter section.
• the distal end of the distal constant diameter section may define a distal end of the core wire.
• the distal end of the first tapered section may be attached to the proximal end of the distal constant diameter section such that a first inflection point is defined where the distal end of the first tapered section and the proximal end of the distal constant diameter section meet.
• the distal end of the intermediate constant diameter section may be attached to the proximal end of the first tapered section.
• the distal end of the second tapered section may be attached to the proximal end of the intermediate constant diameter section such that a second inflection point is defined where the distal end of the second tapered section and the proximal end of the intermediate constant diameter section meet.
• the distal end of the proximal constant diameter section may be attached to the proximal end of the second tapered section.
• the core wire may be configured such that when a first predetermined longitudinal force is applied to the distal end of the distal constant diameter section along the longitudinal axis, the distal constant diameter section prolapses such that a first loop is defined about the first inflection point.
• Another example medical guidewire may include a core wire comprising a superelastic material and having a longitudinal axis.
• the core wire may include a distal constant diameter section including a proximal end and a distal end.
• the distal end may define a distal end of the core wire.
• the distal constant diameter section may have a length in the range of 0.1cm to 2.5 cm and a diameter in the range of 0.001 inches to 0.008 inches.
• the core wire may also include a tapered section having a proximal end and a distal end.
• the distal end may be attached to the proximal end of the distal constant diameter section such that a first inflection point is defined where the distal end of the tapered section and the proximal end of the distal constant diameter section meet.
• the tapered section may have a length in the range of 0.5cm to 3cm.
• the core wire may also include a proximal portion having a distal end attached to the proximal end of the tapered section.
• the core wire may be configured such that when a predetermined longitudinal force is applied to the distal end of the distal constant diameter section along the longitudinal axis, the distal constant diameter section prolapses such that a loop is defined about the inflection point.
• the methods may include providing or otherwise using a guidewire such as the guidewires disclosed herein.
• the method may also include contacting a distal end of the guidewire with tissue in or adjacent to the opening, applying a first predetermined longitudinal force to the distal end of the core wire along the longitudinal axis such that a loop is formed in the guidewire, and advancing the loop formed in the guidewire into the opening.
• An example medical device may include an elongate shaft having a distal constant diameter section, a first tapered section attached to the distal constant diameter section, an intermediate constant diameter section attached to the first tapered section, a second tapered section attached to the intermediate constant diameter section, and a proximal constant diameter section attached to the second tapered section.
• the distal constant diameter section may have a length in the range of 0.1cm to 2.5 cm.
• a first inflection point may be defined in the shaft where the distal constant diameter section and the first tapered section meet.
• the shaft may be configured to form a first loop at the first inflection point when subjected to a first pre-determined longitudinal force.
• a second inflection point may be defined in the shaft where the intermediate constant diameter section and the second tapered section meet.
• the shaft may be configured to form a second loop at the second inflection point when subjected to a second pre-determined longitudinal force.
• the first predetermined force may be in the range of 20g to 200g.
• the second predetermined force may be in the range of 250g to 700.
• Figure 1 is a partial cross-sectional side view of an example guidewire
• Figure 2 is a side view of an example core wire
• Figure 3 is a side view of an example core wire with a loop formed therein at a first deflection point
• Figure 4 is a side view of an example core wire with a loop formed therein at a second deflection point
• Figures 5-7 are plan views depicting an example guidewire being advanced to a target region.
• references in the specification to "an embodiment”, “some embodiments”, “other embodiments”, etc. indicate that the embodiment described may include one or more particular features, structures, and/or characteristics. However, such recitations do not necessarily mean that all embodiments include the particular features, structures, and/or characteristics. Additionally, when particular features, structures, and/or characteristics are described in connection with one embodiment, it should be understood that such features, structures, and/or characteristics may also be used connection with other embodiments whether or not explicitly described unless clearly stated to the contrary.
• Figure 1 is a partial cross-sectional side view of an example guidewire 10.
• Guidewire 10 may include a core wire 12.
• a sheath 14 may be disposed along at least a portion of core wire 12.
• a tip member 16 may be disposed about a portion of core wire 12.
• Core wire 12 may include a first or distal constant diameter section 18.
• a first tapered section 20 may be coupled to distal constant diameter section 18.
• a proximal end of distal constant diameter section 18 may be attached to a distal end of first tapered section 20.
• a second or intermediate constant diameter section 22 may be coupled to first tapered section 20.
• a proximal end of first tapered section 20 may be attached to a distal end of intermediate constant diameter section 22.
• a second tapered section 24 may be coupled to intermediate constant diameter section 22.
• a proximal end of intermediate constant diameter section 22 may be attached to a distal end of second tapered section 24.
• a third or proximal constant diameter section 26 may be coupled to second tapered section 24.
• a proximal end of second tapered section 24 may be attached to a distal end of proximal constant diameter section 26.
• core wire 12 may be a unitary structure or otherwise formed from a single monolith of material. In other embodiments, core wire 12 may be formed from a plurality of different structures that are secured together. This may include one or more of sections 18/20/22/24/26 being separate structures that are secured to the remaining sections of core wire 12. In such embodiments, the one or more separate structures may be secured to remaining sections of core wire 12 using a suitable bonding technique such as welding, brazing, thermal bonding, adhesive bonding, mechanical bonding and/or the use of a mechanical connector, or the like.
• the dimensions of core wire 12 may vary. Disclosed herein are some example dimensions for the various sections of core wire 12. These dimensions are meant to be examples and are not intended to be limiting. Other dimensions are contemplated.
• proximal constant diameter section 26 may have a length (represented in Figure 1 as dimension Dl) of about 200-600cm (78.4- 236.2 inches), or about 260-500cm (102.4-196.9 inches).
• the diameter of proximal constant diameter section 26 may be about 0.01-0.04 inches, or about 0.015-0.030 inches, or about 0.023 inches.
• Second tapered section 24 may have a length (represented in Figure 1 as dimension D2) of about l-50cm (0.4-19.7 inches), or about 2-50cm (0.8-19.7 inches), or about 2-15cm (0.8-5.9 inches), or about 2-lOcm (0.8-3.9 inches), or about 5 cm (2 inches).
• the diameter of second tapered section 24 may vary from a diameter that is equal to or approximately equal to the diameter of proximal constant diameter section 26 to a diameter that is equal to or approximately equal to the diameter of intermediate constant diameter section 22.
• the transition in diameter may be a linear taper or non-linear taper.
• the tapering of second tapered section 24 may be a parabolic taper, a curvilinear taper, a straight taper, a function of a non-linear equation (e.g., a second order equation, a third order equation, a fourth order equation, or the like), or the like.
• the taper may be constant along the length of second tapered section 24 or the taper may vary along the length.
• the taper may include one or more steps in diameter.
• Intermediate constant diameter section 22 may have a length (represented in Figure 1 as dimension D3) of about 0.5-20cm (0.2-7.9 inches), or about 1-lOcm (0.4-4 inches), or about 2.5-7.5cm (1-3 inches).
• the diameter of intermediate constant diameter section 22 may be about 0.001-0.04 inches, or about 0.005-0.015 inches, or about 0.01 inches.
• First tapered section 20 may have a length (represented in Figure 1 as dimension D4) of about 0.1-lOcm (0.04-4 inches), or about 0.5-lOcm (0.2-4 inches), or about 0.5-3cm (0.2-1.2 inches), or about 1 cm (0.4 inches).
• the diameter of first tapered section 20 may vary from a diameter that is equal to or approximately equal to the diameter of intermediate constant diameter section 22 to a diameter that is equal to or approximately equal to the diameter of distal constant diameter section 18.
• the transition in diameter may be a linear taper or non-linear taper.
• first tapered section 20 may be a parabolic taper, a curvilinear taper, a straight taper, a function of a non-linear equation (e.g., a second order equation, a third order equation, a fourth order equation, or the like), or the like.
• the taper may be constant along the length of first tapered section 20 or the taper may vary along the length.
• the taper may include one or more steps in diameter.
• Distal constant diameter section 18 may have a length (represented in Figure 1 as dimension D5) of about 0.1-5cm (0.04-2 inches), or about 0.1-2.5cm (0.04-1 inches), or about 1.5cm (0.6 inches).
• the diameter of distal constant diameter section 18 may be about 0.001-0.02 inches, or about 0.001-0.008 inches, or about 0.005 inches.
• the ratio of length of distal constant diameter section 18 to the diameter of distal constant diameter section 18 may be in the range of about 100: 1-1500: 1, or about 200: 1-1200: 1, or about 800: 1-1200: 1.
• distal constant diameter section 18 may have a cross- sectional shape that is substantially round. In other embodiments, distal constant diameter section 18 may be flattened or otherwise have a non-circular cross-sectional shape.
• Forming core wire 12 may include a grinding technique such as through the use of a centerless grinder.
• a centerless grinder may be used to form core wire 12.
• the centerless grinding teachnique may be modified to use a thinner cutting wheel, which may allow for greater precision and/or for the creature of increasing and decreasing tapers along the length of core wire 12.
• different grinding modes may be used to form the desired configuration of core wire 12 such as "OD" mode.
• Guidewires for using in coronary interventions are often designed to have a relatively stiff proximal section for providing "pushability" and a relatively flexible distal region and/or tip.
• coronary guidewires may be designed to avoid kinking or prolapsing when being advanced through a blood vessel.
• a kinked or prolapsed guidewire may not be fully functional and may not be suitable for guiding other diagnostic and/or therapeutic devices to a target region.
• Guidewire 10 may find utility for use in endoscope interventions such as accessing the common bile duct (and/or the biliary tree), the pancreatic duct (and/or the pancreatic tree), or the like.
• guidewire 10 is designed to have one or more pre-determined inflection points where guidewire 10 may prolapse or otherwise form a loop.
• This design may desirably allow guidewire 10 to be used in endoscopic interventions or otherwise be used along the biliary or pancreatic tree.
• the ability of guidewire 10 to form a predictable, predetermined loop configuration may desirably impact the ability of guidewire 10 to cannulate anatomical structures such as the papilla of Vater, gain access to body lumens such as the common bile duct and/or the pancreatic duct, or otherwise perform endoscopic interventions.
• first inflection point 28 may be defined where distal constant diameter section 18 and first tapered section 20 meet. Because of the length of distal constant diameter section 18, first inflection point 28 may be positioned relatively close to the distal end of guidewire 10. When guidewire 10 is subjected to a suitable longitudinal force, distal constant diameter section 18 may prolapse or otherwise form a loop as shown in Figure 3. In at least some embodiments, the amount of force may be relatively low. For example, guidewire 10 may form the loop at first inflection point 28 when subjected to about 20-200g of longitudinal force, or about 20-200g of longitudinal force.
• the amount of longitudinal force that may cause guidewire 10 to form a loop at first inflection point 28 may be about 1.1-2.0 times the insertion force (e.g., the force needed to insert guidewire 10 into a catheter, endoscope, or another device), or about 1.2-1.5 times the insertion force, or about 1.25 times the insertion force.
• first inflection point 28 is positioned close to the distal end of guidewire 10, the loop formed when guidewire 10 may be shorter, more tightly associated with the rest of the guidewire (e.g., the radius of curvature may be kept to a minimum), and less force may be applied to the surrounding anatomy.
• guidewire 10 may form a loop more easily, may have a better "feel” for clinicians, and may also be able to revert back to a linear state more easily and/or with less trauma to the surrounding tissue.
• the guidewire 10 may be able to "flick” or otherwise snap back to a more "unlooped” state so that guidewire 10 can continue to advance through the anatomy.
• guidewire 10 may include a plurality of inflection points.
• a second inflection point 30 may be defined where intermediate constant diameter section 22 and second tapered section 24 meet.
• the sections of core wire 12 distal of second inflection point 30 may prolapse or otherwise form a loop as shown in Figure 4.
• the amount of force may greater than that of first inflection point 28.
• guidewire 10 may form the loop at second inflection point 30 when subjected to about 250-700g of longitudinal force.
• the amount of longitudinal force that may cause guidewire 10 to form a loop at second inflection point 30 may be about 1.75-2.5 times the insertion force (e.g., the force needed to insert guidewire 10 into a catheter, endoscope, or another device), or about 1.8-2.2 times the insertion force, or about 2 times the insertion force.
• guidewire 10 may form a loop at a specific location along the length thereof, with a specific force, and with a controlled (and/or reduced) circumferential force on the body lumen.
• inflection points 28/30 may be defined where a constant diameter section meets a tapered section.
• other structural modifications may also be utilized to define an inflection point such as stiffened regions of core wire 12, structures secured to core wire 12 to impart stiffness, changes in the location and/or composition of the sections of core wire 12, changes in the composition and/or location of sheath 14 and/or tip member 16, or the like.
• guidewire 10 may be advanced through a body lumen such as the duodenum 32 to a position adjacent to the papilla of Vater 34 as shown in Figure 5. This may include the use of a cannulation or guide catheter 36 and/or an endoscope 38. Guidewire 10 may be advanced out from guide catheter 36 and into engagement with the papilla of Vater 34. If a suitable amount of resistance is encountered, guidewire 10 may prolapse or form a loop a first inflection point 28 as shown in Figure 6.
• Guidewire 10 may be advanced through the papilla of Vater 34 to a suitable diagnostic and/or treatment site such as along the biliary tract (e.g., the common bile duct 40) or the pancreatic tract (e.g., the pancreatic duct 42).
• a suitable diagnostic and/or treatment site such as along the biliary tract (e.g., the common bile duct 40) or the pancreatic tract (e.g., the pancreatic duct 42).
• guidewire 10 is shown advanced into the common bile duct 40 in Figure 7.
• the materials that can be used for the various components of guidewire 10 may include metals, metal alloys, polymers, metal-polymer composites, ceramics, combinations thereof, and the like, or other suitable materials.
• suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, for example, DELRTN® available from DuPont), polyether block ester, polyurethane (for example, Polyurethane 85A), polypropylene (PP), polyvinylchloride (PVC), polyether-ester (for example, AR ITEL® available from DSM Engineering Plastics), ether or ester based copolymers (for example, butylene/poly(alkylene ether) phthalate and/or other polyester elastomers such as HYTREL® available from DuPont), polyamide (for example, DURETHAN® available from Bayer or CRISTAMID® available from El
• suitable metals and metal alloys include stainless steel, such as 304V, 304L, and 316LV stainless steel; mild steel; nickel-titanium alloy such as linear-elastic and/or super-elastic nitinol; other nickel alloys such as nickel- chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL® 625, UNS: N06022 such as HASTELLOY® C-22®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copper alloys (e.g., UNS: N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N® and the like), nickel-molybdenum alloys (e.
• Linear elastic and/or non-super-elastic nitinol may be distinguished from super elastic nitinol in that the linear elastic and/or non-super-elastic nitinol does not display a substantial "superelastic plateau” or “flag region” in its stress/strain curve like super elastic nitinol does.
• linear elastic and/or non-super-elastic nitinol as recoverable strain increases, the stress continues to increase in a substantially linear, or a somewhat, but not necessarily entirely linear relationship until plastic deformation begins or at least in a relationship that is more linear that the super elastic plateau and/or flag region that may be seen with super elastic nitinol.
• linear elastic and/or non-super-elastic nitinol may also be termed "substantially" linear elastic and/or non-super-elastic nitinol.
• linear elastic and/or non-super-elastic nitinol may also be distinguishable from super elastic nitinol in that linear elastic and/or non-super-elastic nitinol may accept up to about 2-5% strain while remaining substantially elastic (e.g., before plastically deforming) whereas super elastic nitinol may accept up to about 8% strain before plastically deforming. Both of these materials can be distinguished from other linear elastic materials such as stainless steel (that can also can be distinguished based on its composition), which may accept only about 0.2 to 0.44 percent strain before plastically deforming.
• the linear elastic and/or non-super-elastic nickel- titanium alloy is an alloy that does not show any martens ite/austenite phase changes that are detectable by differential scanning calorimetry (DSC) and dynamic metal thermal analysis (DMTA) analysis over a large temperature range.
• DSC differential scanning calorimetry
• DMTA dynamic metal thermal analysis
• the mechanical bending properties of such material may therefore be generally inert to the effect of temperature over this very broad range of temperature.
• the mechanical bending properties of the linear elastic and/or non-super-elastic nickel- titanium alloy at ambient or room temperature are substantially the same as the mechanical properties at body temperature, for example, in that they do not display a super-elastic plateau and/or flag region.
• the linear elastic and/or non-super-elastic nickel-titanium alloy maintains its linear elastic and/or non-super-elastic characteristics and/or properties.
• the linear elastic and/or non-super-elastic nickel- titanium alloy may be in the range of about 50 to about 60 weight percent nickel, with the remainder being essentially titanium. In some embodiments, the composition is in the range of about 54 to about 57 weight percent nickel.
• a suitable nickel-titanium alloy is FHP-NT alloy commercially available from Furukawa Techno Material Co. of Kanagawa, Japan. Some examples of nickel titanium alloys are disclosed in U.S. Patent Nos. 5,238,004 and 6,508,803, which are incorporated herein by reference. Other suitable materials may include ULTANIUMTM (available from Neo-Metrics) and GUM METALTM (available from Toyota).
• a superelastic alloy for example a superelastic nitinol can be used to achieve desired properties.
• portions or all of core wire 12 may also be doped with, made of, or otherwise include a radiopaque material.
• Radiopaque materials are understood to be materials capable of producing a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image aids the user of guidewire 10 in determining its location.
• Some examples of radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloy, polymer material loaded with a radiopaque filler, and the like. Additionally, other radiopaque marker bands and/or coils may also be incorporated into the design of guidewire 10 to achieve the same result.
• a degree of Magnetic Resonance Imaging (MRI) compatibility is imparted into guidewire 10.
• core wire 12, or portions thereof may be made of a material that does not substantially distort the image and create substantial artifacts (i.e., gaps in the image). Certain ferromagnetic materials, for example, may not be suitable because they may create artifacts in an MRI image. Core wire 12, or portions thereof, may also be made from a material that the MRI machine can image.
• Some materials that exhibit these characteristics include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., U S: R30003 such as ELGILOY®, PHY OX®, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N® and the like), nitinol, and the like, and others.
• cobalt-chromium-molybdenum alloys e.g., U S: R30003 such as ELGILOY®, PHY OX®, and the like
• nickel-cobalt-chromium-molybdenum alloys e.g., UNS: R30035 such as MP35-N® and the like
• nitinol and the like, and others.
• the entire core wire 12 can be made of the same material along its length, or in some embodiments, can include portions or sections made of different materials.
• the material used to construct core wire 12 is chosen to impart varying flexibility and stiffness characteristics to different portions of core wire 12.
• the different portions can be connected using a suitable connecting technique and/or with a connector.
• the different portions of core wire 12 can be connected using welding (including laser welding), soldering, brazing, adhesive, or the like, or combinations thereof. These techniques can be utilized regardless of whether or not a connector is utilized.

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• Health & Medical Sciences (AREA)
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• Anesthesiology (AREA)
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• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
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• Media Introduction/Drainage Providing Device (AREA)
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• Surgical Instruments (AREA)

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• 2014
  • 2014-11-20 EP EP14808795.0A patent/EP3074079B1/de active Active
  • 2014-11-20 CN CN201480074033.9A patent/CN106413794A/zh active Pending
  • 2014-11-20 WO PCT/US2014/066665 patent/WO2015080948A1/en active Application Filing
  • 2014-11-20 US US14/549,191 patent/US20150148706A1/en not_active Abandoned
  • 2014-11-20 JP JP2016534202A patent/JP2017500925A/ja active Pending

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